Analytical quality by design approach versus conventional approach: Development of HPLC-DAD method for simultaneous determination of etizolam and propranolol hydrochloride

References

• Mohamed, B.; Donia, A.; Nabila Bakry, M.; Harold Strauss, C. Sequential Thin Layer Chromatography of Propranolol. J. Chromatogr. A. 1979, 172, 463–467. DOI: 10.1016/S0021-9673(00)90998-1.
   Web of Science ®Google Scholar
• Payal, K.; Parag, P.; Nikita, P.; Kulkarni, G.; Bhawan Kumar, P. Stability Indicating RP-HPLC Method Development and Validation of Etizolam and Propranolol HCl in Pharmaceutical Dosage Form. World J. Pharm. Sci. 2015, 3, 1113–1124.
   Google Scholar
• Chatterjee, S. QbD Considerations for Analytical methods – FDA Perspective. Presented at the IFPAC Annual Meeting, Baltimore, CMC Lead for QbD ONDQA/CDER/FDA. https://qbdworks.com/wp-content/uploads/2014/06/AnalyticalQbDIFPAC.pdf (accessed Jan 25, 2013).
   Google Scholar
• Tang, Y. QbD Approaches to Analytical Methods – FDA Perspective. FDA/CDER/ONDQA, AAPS: Washington, DC, 2011. https://www.fda.gov/downloads/AboutFDA/CentersOffices/…/CDER/UCM301056.pdf; https://www.fda.gov/media/84046/download (accessed Oct 25, 2011).
   Google Scholar
• Ermer, J. Quality by Design in Pharmaceutical Analysis Conference Organized by European Compliance Academy, Vienna, Austria, 2013. http://www.gmp-compliance.org/daten/seminarpdf.archiv/ECA_QbD_in_Analysis_2013.pdf.
   Google Scholar
• International Conference on Harmonization (ICH) Tripartite Guidelines, ICH Q8 (R2): Pharmaceutical Development, Toronto, 2009.
   Google Scholar
• International Conference on Harmonization (ICH) Tripartite Guidelines, ICH Q9: Quality Risk Management, Toronto, 2006.
   Google Scholar
• International Conference on Harmonization (ICH) Tripartite Guidelines, ICH Q10: Pharmaceutical Quality System, Toronto, 2008.
   Google Scholar
• Ramalingam, P.; Bhadraya, K.; Padmanabha Reddy, Y. Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics. Int. J. Anal. Chem. 2015, 2015, 868719–868727. DOI: 10.1155/2015/868727.
   Web of Science ®Google Scholar
• Peraman, R.; Kalva, B.; Shanka, S.; Reddy, Y. P. Analytical Quality by Design (AQbD) Approach to Liquid Chromatographic Method for Quantification of Acyclovir and Hydrocortisone in Dosage Forms. Anal. Chem. Lett. 2014, 4, 329–342. DOI: 10.1080/22297928.2014.999121.
   Google Scholar
• Peraman, R.; Bhadraya, K.; Reddy, Y. P.; Reddy, C. S.; Lokesh, T. Analytical Quality by Design Approach in RP-HPLC Method Development for the Assay of Etofenamate in Dosage Forms. Indian J. Pharm. Sci. 2015, 77, 751–757. DOI: 10.4103/0250-474x.174971.
   PubMed Web of Science ®Google Scholar
• Khan, A.; Imam, S. S.; Aqil, M.; Sultana, Y.; Ali, A.; Khan, K. Design of Experiment Based Validated Stability Indicating RP-HPLC Method of Temozolomide in Bulk and Pharmaceutical Dosage Forms. Beni Suef Univ. J. Basic Appl. Sci. 2016, 5, 402–408. Dec 1, . DOI: 10.1016/j.bjbas.2015.11.011.
   Google Scholar
• Imam, S. S.; Aqil, M.; Akhtar, M.; Sultana, Y.; Ali, A. Optimization of Mobile Phase by 32-Mixture Design for the Validation and Quantification of Risperidone in Bulk and Pharmaceutical Formulations Using RP-HPLC. Anal. Methods 2014, 6, 282–288. DOI: 10.1039/C3AY41562G.
   Web of Science ®Google Scholar
• Sachin, B. G.; Rani, R. A.; Omprakash, G. B.; Sanjay, S. T. Analytical Method Development and Validation by QbD Approach. Der. Pharmacia. Sinica. 2015, 6, 18–24.
   Google Scholar
• Sethy, S. P.; Sameena, T.; Prathima, P.; Shailaja, K. Product Life Cycle Management in Pharmaceuticals. Pharmatutor online; Article Reference 2051. https://www.pharmatutor.org/articles/product-life-cycle-management-in-pharmaceuticals-review.
   Google Scholar
• Todd, H. Product Lifecycle Management for the Pharmaceutical Industry. Improving Clinical Development and Manufacturing Processes in Pharmaceuticals; Oracle Pharmaceutical Solution Set. Oracle Life Sciences, pp 1–9. https://www.oracle.com/assets/lifecycle-mgmt-pharmaceutical-bwp-070014.pdf
   Google Scholar
• Bhumika Sakhreliya, D.; Priti Trivedi, D.; Darshana Modi, K. Development and Validation of Spectrophotometric Methods for Simultaneous Estimation of Escitalopram Oxalate and Etizolam in Their Combined Tablet Dosage Form. J. Pharm. Sci. Biosci. Res. 2012, 2, 195–200.
   Google Scholar
• Devi Swapna, P. V.; Das, P.; Chetan, S. H.; Reddy, J. Analytical Method Development and Validation for the Simultaneous Estimation of Propranolol Hydrochloride and Etizolam in Their Combined Dosage Form by Vierodt’s Method. Int. J. Pharm. Biol. Chem. Sci. 2014, 3, 46–50.
   Google Scholar
• Shivarkar, N. A.; Dudhe, P. B.; Nagras, S. Development and Validation of HPTLC Method for Simultaneous Quantification of Flunarizine Dihydrochloride and Propranolol Hydrochloride in Bulk Drug and Capsule. Indian J. Pharm. Sci. 2013, 75, 364–368. DOI: 10.4103/0250-474X.117418.
   PubMed Web of Science ®Google Scholar
• Vijay Kumar, G.; Shashikala, P. Analytical Method Development and Validation by RP-HPLC for Simultaneous Estimation of Etizolam and Propranolol in Combined Tablet Dosage. Asian J. Med. Pharm. Sci. 2015, 3, 299–306.
   Google Scholar
• Uma Maheshwari, D.; Jayakar, B. RP-HPLC Method for Simultaneous Determination of Etizolam and Propranolol in Pure and Its Tablet Dosage Form. Int. J. Pharm. Chem. Biol. Sci. 2015, 5, 213–216.
   Google Scholar
• Devi Swapna, P. V.; Das, P.; Chetan, S. H.; Reddy, J. Method Development and Validation of Simultaneous Estimation of Propranolol HCL and Etizolam by RPHPLC. Am. J. PharmTech. Res. 2014, 4, 46–50.
   Google Scholar
• Prasenjit, M.; Santhosh, B.; Sobha Rani, S.; Ramakrishna, R. A New Validated Simultaneous RP-HPLC Method for Estimation of Escitalopram Oxalate and Etizolam in Bulk and Tablet Dosage Form. Der. Pharma. Chemica. 2013, 5, 26–32.
   Google Scholar
• Imam, S. S.; Ahad, A.; Aqil, M.; Sultana, Y.; Ali, A. A Validated RP-HPLC Method for Simultaneous Determination of Propranolol and Valsartan in Bulk Drug and Gel Formulation. J. Pharm. Bioallied Sci. 2013, 5, 61–65.
   PubMedGoogle Scholar
• Chiragkumar, R. P.; Prajapati, Y.; Bhumika Sakhreliya, M. S. Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Etizolam in Tablet Dosage Form. JPSBR 2014, 4, 270–275.
   Google Scholar
• Helboe, P. Determination of Impurities in Propranolol Hydrochloride by High Performance Liquid Chromatography on Dynamically Modified Silica. J. Chromatogr. A. 1982, 245, 229–238. DOI: 10.1016/S0021-9673(00)88592-1.
   PubMed Web of Science ®Google Scholar
• Shalini, S.; Ajitha, A.; Uma Maheshwara Rao, V. Analytical Method Development and Validation for Simultaneous Estimation of Escitalopram Oxalate and Etizolam in a Combined Dosage Form by RP-HPLC. IJIPSR 2014, 2, 2169–2178.
   Google Scholar
• Tulja Rani, G.; Gowri Shankar, D.; Kadgapathi, P.; Satyarayana, B. Development of an RP-HPLC Method for Simultaneous Estimation of Propranolol Hydrochloride and Diazepam in Combined Dosage Form. IJPER 2011, 45, 296–300.
   Google Scholar
• Shalini, Y.; Sai Annapurneswari, T.; Sundari Ch, B. T.; Jayathirtha Rao, V.; Ravinder Nath, A. Method Development and Validation for Simultaneous Estimation of Propranolol Hydrochloride and Flunarizine Dihydrochloride in Bulk and Pharmaceutical Dosage Form by RP-HPLC. Int. Res. J. Pharm. App. Sci. 2012, 2, 143–148.
   Google Scholar
• Geiser, F.; Schultz, M.; Betz, L.; Shaimi, M.; Lee, J.; Champion, W. Jr. Direct Preparative Enantio Selective Chromatography of Propranolol Hydrochloride and Thioridazine Hydrochloride Using Carbon Dioxide Based Mobile Phases. J. Chromatogr. A. 1999, 865, 227–233. DOI: 10.1016/S0021-9673(99)01117-6.
   PubMed Web of Science ®Google Scholar
• Savita Yadav, S.; Janhavi Rao, R. Quantitative Estimation of Propranolol Hydrochloride and Hydrochlorothiazide in Pharmaceutical Dosage Form by Micellar Liquid Chromatography. Der Pharmacia Lettre. 2016, 8, 282–288.
   Google Scholar
• Katja, C. T.; Jurij, T.; Jochen, S.; Mitja, L.; Mojca, K. K. Liquid Chromatography-Tandem Mass Spectrometry Method for Simultaneous Quantification of Bisoprolol, Ramipril, Propranolol and Midazolam in Rat Dried Blood Spots. J. Chromatogr. B. 2014, 958, 29–35. DOI: 10.1016/j.jchromb.2014.03.009.
   PubMed Web of Science ®Google Scholar
• Pettersson Bergstrand, M.; Helander, A.; Beck, O. Development and Application of a Multi-Component LC-MS/MS Method for Determination of Designer Benzodiazepines in Urine. J. Chromatogr. B Anal. Technol. Biomed. Life Sci. 2016, 1035, 104–110. DOI: 10.1016/j.jchromb.2016.08.047.
   PubMed Web of Science ®Google Scholar
• Pujos, E.; Cren-Olive, C.; Paisse, O.; Flament-Waton, M. M.; Grenier-Loustalot, M. F. Comparison of the Analysis of Beta-Blockers by Different Techniques. J. Chromatogr. B Anal. Technol. Biomed. Life Sci. 2009, 877, 4007–4014. DOI: 10.1016/j.jchromb.2009.10.014.
   PubMed Web of Science ®Google Scholar
• Yuan Qing, X.; Bakhtiar, R.; Ronald Franklin, B. Automated Online Dual-Column Extraction Coupled with Teicoplanin Stationary Phase for Simultaneous Determination of (R)- and (S)-Propranolol in Rat Plasma Using Liquid Chromatography-Tandem Mass Spectrometry. J. Chromatogr. B. 2003, 788, 317–329. DOI: 10.1016/S1570-0232(03)00036-9.
   PubMed Web of Science ®Google Scholar
• Svan, A.; Mikael, H.; Torbjorn Arvidsson, J.; Jasper, T.; David Sedlak, L.; Pettersson, C. E. Rapid Chiral Separation of Atenolol, Metoprolol, Propranolol and Zwitterionic Metoprolol Acid Using Supercritical Fluid Chromatography-Tandem Mass spectrometry-Application to Wetland Microcosms. J. Chromatogr. A. 2015, 1409, 251–258. DOI: 10.1016/j.chroma.2015.07.075.
   PubMed Web of Science ®Google Scholar
• Di Salle, E.; Baker, K. M.; Bareggi, S. R.; Watkins, W. D.; Chidsey, C. A.; Frigerio, A.; Morselli, P. L. A Sensitive Gas Chromatographic Method for the Determination of Propranolol in Human Plasma. J. Chromatogr. A. 1973, 84, 347–353. DOI: 10.1016/S0021-9673(01)91714-5.
   PubMed Web of Science ®Google Scholar
• Liang, M.; Binling, Z.; Kefang, Z.; Shanlin, F. Ultra Sound – Assisted Low Density Solvent Dispersive Liquid-Liquid Micro Extraction for Determination of 4 Designer Benzodiazepines in Urine Sample by Gas Chromatography – Triple Quadrupole Mass Spectroscopy. J. Chromatogr. B. 2017, 1053, 9–15. DOI: 10.1016/j.jchromb.2017.04.008.
   PubMed Web of Science ®Google Scholar
• David Saelens, A.; Thomas, W.; Philip Privitera, J. Quantitative Determination of Propranolol, Propranolol Glycol and N-Desisopropyl Propranolol in Brain Tissue by Electron Capture Gas Chromatography. J. Chromatogr. A. 1976, 123, 185–192. DOI: 10.1016/S0021-9673(00)81114-0.
   Web of Science ®Google Scholar
• Gustavo Amadeu, M.; Ana Carolina Costa, O.; Heller, M.; Barcellos, M.; Piovezan, M.; Caon, T.; Augusto Leal de Oliveira, M. Development of a Fast Capillary Electrophoresis Method for the Determination of Propranolol-Total Analysis Time Reduction Strategies. J. Chromatogr. A. 2009, 1216, 7957–7961. DOI: 10.1016/j.chroma.2009.08.083.
   PubMed Web of Science ®Google Scholar
• Pak, C.; Marriott, P. J.; Carpenter, P. D.; Amiet, R. G. Enantiomeric Separation of Propranolol and Selected Metabolites by Using Capillary Electrophoresis with Hydroxypropyl-β-Cyclodextrin as Chiral Selector. J. Chromatogr. A. 1998, 793, 357–364. DOI: 10.1016/S0021-9673(97)00919-9.
   PubMed Web of Science ®Google Scholar
• Xingwang, Z.; Xiujuan, L.; Zhaorui, Z. Solid Phase Micro Extraction Coupled with Capillary Electrophoresis for Determination of Propranolol Enantiomers in Urine Using a Sol-Gel Derived Calix [4] Arene Fiber. J. Chromatogr. A. 2006, 1104, 359–365. DOI: 10.1016/j.chroma.2005.11.126.
   PubMed Web of Science ®Google Scholar
• International Conference on Harmonization (ICH) Tripartite Guidelines, ICH Q2: Validation of Analytical Procedures (R1), Toronto, 2005.
   Google Scholar